An experienced litigator, Kimberly Castellino Metzger plays an integral role on national counsel teams representing pharmaceutical manufacturers in courts across the country. She frequently collaborates as either national or local counsel, working closely with co-defendants and other attorneys to achieve favorable results for her clients. Kim has extensive experience with pretrial proceedings, including expert, fact witness and 30(b)(6) depositions, dispositive motion practice, Daubert proceedings, and mediation. She enjoys the challenge of becoming a “non-scientist scientist” as she learns about the disease states, medicine, product science, and epidemiology underlying cases she prepares for trial.
As part of Kim’s healthcare-focused practice, she regularly counsels HIPAA-regulated entities (health care providers, health plans, and their business associates), as well as manufacturers of pharmaceuticals, medical devices, and cosmetics and personal care products, on complex data security and privacy issues, including HIPAA’s Privacy, Security, and Breach Notification Rules, the Cures Act, and GDPR compliance. Kim has earned several certifications through the International Association of Privacy Professionals (IAPP). Her qualifications include:
- Certified Information Privacy Professional/U.S. Private Sector (CIPP/US).
- Certified Information Privacy Professional/Europe (CIPP/E), and Certified Information Privacy Manager (CIPM) an industry-recognized combination for GDPR compliance.
- Fellow of Information Privacy (FIP) in IAPP’s inaugural class in 2016.
Kim has worked with the HIPAA regulations for almost two decades and has extensive experience with and a deep understanding of these and other federal and state health information privacy laws. She works closely with large and small clients to establish and maintain HIPAA-compliant privacy programs – from the ground up, where needed – and counsels them on responding to security incidents and potential data breaches. Kim also proactively and responsively trains clients’ workforces, including the C-suite, on HIPAA privacy and security compliance in an effort to respond to and prevent breaches, and safeguard patient privacy.
Kim’s practice also includes counseling pharmaceutical drug and medical device companies on various aspects of FDA regulatory compliance, including product classification, registration and listing, and product recalls. She has served on medical-legal-regulatory pre- and post-launch teams to evaluate product claims and warnings, and has worked closely with clients to evaluate product risk.
Kim is a lifelong Midwesterner and worked as a child welfare case manager and therapist before entering law school. She has had in-house experience as an associate director/general counsel for a large community mental health center in Northern Indiana. Kim is passionate about diversity, equity, and inclusion, and has worked on a variety of DEI initiatives, particularly in the LGBTQ+ space. She enjoys mentoring law students and early-career attorneys. Kim and her husband, Rick, have four children.